In order to provide you a level of certainty in planning in
the face of the COVID-19 situation, this event is now being delivered online as
an online workshop. We are working with our instructors to ensure
that the same learning objectives and quality of the education will be delivered
regardless of this modification. RAPS is closely monitoring developments in the
Coronavirus (COVID-19) outbreak. See our public safety page for
the latest updates.
With an emphasis on product development challenges and
regulatory expectations in the US, Europe and other highly regulated regions,
this workshop provides an in-depth study of chemistry, manufacturing and
control (CMC) product development requirements and best practices associated
with biologics, biosimilars, gene therapy and cell therapy products.
Specifically designed for RA/QA professionals, managers
and scientists responsible for biopharmaceutical CMC development and preparation
of dossiers, this in-depth discussion will take a regulatory approach to the
technical issues that arise during biologic product development and
registration.
Topics will include:
·
Biological product development from early
phase to commercialization
·
Source material
·
Cell & seed banks
·
Upstream and downstream processing,
formulation and final product production
·
Characterization and testing
·
Demonstrating comparability
·
CMC regulations and guidance applicable to
biologics
·
Quality by Design
·
Adventitious agents risk management
Faculty
Patricia Cash, PhD, Independent Biotechnology Consultant
Joseph Quinn, Biologics Regulatory Consultant
Mark
Schenerman, CMC
Biotech-MAS Consulting and University of Maryland – Baltimore County
Location
Online Workshop
Registration Fees
Registration 6 July 2020
RAPS
Members: $800
Nonmembers: $900
Registration from 7 July 4 August
RAPS
Members: $900
Nonmembers: $1,000
Advance
registration is required for this workshop. Participants are encouraged to register
early. Onsite registrations are not accepted.
Registration Closes:
4 August
RAC Credits:
12
RAC
Will
this meeting be recorded? Yes – recordings are only accessible
post-event to program registrants.
Proof of Attendance: An
electronic letter of attendance will be sent upon request.
Day 1
(9:00 am – 5:00 pm)
•
Overview of types of biologic products
(therapeutic proteins, antibodies, drug-antibody conjugates, vaccines, gene
therapies, cell-based therapies)
•
Establishing the TPP and QTPP, important
drivers for product development
•
Quality by Design
•
Clinical-phase-appropriate regulatory
compliance in the development and establishment of manufacturing and control
strategies for biologics and biosimilars. Each of the topics that follow will
be discussed in depth from an early- and late-phase perspective of regulatory
requirements
o
Cell substrates & source materials, cell banks
(storage, testing and other requirements)
o
Upstream processing (preparation of media,
fermentation, harvesting/recovery, critical process parameters, PAT)
o
Downstream processing (purification
strategies, process impurities, clearance studies)
o
Final product formulation (stability issues,
considerations in choosing storage temp)
Day 2
(9:00 am – 5:00 pm)
•
Clinical-phase-appropriate regulatory
compliance in the development and establishment of manufacturing and control
strategies for biologics and biosimilars (continued). Each of the topics that
follow will be discussed in depth from an early- and late-phase perspective of
regulatory requirements
o
Characterization Testing
o
Determination of cQAs
o
Release and Stability Testing (Control
Strategy)
o
Setting Specifications
o
Validation of analytical methods
•
Process validation
•
Post approval changes – what is required?
•
Adventitious agents risk management
•
Demonstrating comparability &
comparability protocols
NOTE: The
agenda may vary based on changing requirements.
At the conclusion of this workshop, participants should:
·
Be familiar with various types of biologic
products and their structural/functional characteristics
·
Understand development phase-appropriate
regulatory agency expectations associated with biologics characterization,
development, production and testing
·
Understand best practices in establishing a
comprehensive chemistry, manufacturing, and control (CMC) regulatory strategy
for application to the lifecycle of biologic and biosimilar products
·
Understand Quality by Design principles as
they relate to development, manufacturing, characterizations, and testing of
biologic products
·
Translate an effective biologics CMC strategy
into effective regulatory submission content for biologic and biosimilar
products
Who
Should Attend
This program will benefit early, mid-career, and senior
SMEs and regulatory professionals in CMC working in development, registration
and post-approval lifecycle management for biological products. There are no
prerequisites for participation. It is recommended that Biologics CMC Workshop:
Current Trends, Future Trends and Regulatory Challenges be taken prior to this
course for early career SMEs.
Other Information
Questions? Call RAPS Solutions Center at +1 301.770.2920, ext. 200.
Cancellation
or Substitutions
RAPS
reserves the right to cancel this program at its sole discretion.
All
cancellation requests must be submitted in writing to raps@raps.org. RAPS is
unable to accept cancellations by phone. Please specify the name of the person
registered and event title.
Due to
uncertainty surrounding the COVID-19 situation’s impact on travel our standard
cancellation fees will be waived. Should you need to cancel your registration,
you can apply your credit to any RAPS program for the next 12 months.
Substitutions
may be accepted with written approval from RAPS and must be submitted to
raps@raps.org. Due to uncertainty
surrounding the COVID-19 situation, RAPS will allow substitutions up to the
first day of the event.
Program Contact
Nichelle
Sankey
nsankey@raps.org
+1 301 770
2920, ext. 252